FDA 510(k)

BIOK7600 Flat Panel Detector

K-Number: K190311 · 2019-03-13

Decision Date2019-03-13

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIOK7600 Flat Panel Detector is a medical device manufactured by Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2019-03-13 under approval number K190311. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOK7600 Flat Panel Detector?

BIOK7600 Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2019-03-13. It is manufactured by Biokinemetrics, Inc.. The 510(k) number is K190311.

When was BIOK7600 Flat Panel Detector approved by the FDA?

BIOK7600 Flat Panel Detector received FDA 510(k) clearance on 2019-03-13, under approval number K190311.

What company makes BIOK7600 Flat Panel Detector?

BIOK7600 Flat Panel Detector is manufactured by Biokinemetrics, Inc..

What is the FDA product code for BIOK7600 Flat Panel Detector?

The FDA product code for BIOK7600 Flat Panel Detector is MQB.

Other Devices by Biokinemetrics, Inc.

K181565Aquarius 8600 Digital Radiography Sensor K190300BIOK7600W Wireless Flat Panel Detector

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.